盐酸曲马多口腔崩解片人体相对生物利用度和生物等效性考察  

Study on pharmacokinetecs and bioavailability of tramadol hydrochloride orally disintegrating tablets

作　　者：谌辉[1] 黄厚武[1] 李茜[1] 张营[1] 黎维勇[1] 陈华庭[1] 

机构地区：[1]华中科技大学同济医学院附属协和医院传染科,湖北武汉430022

出　　处：《中国医院药学杂志》2007年第10期1416-1418,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:建立人血浆中曲马多浓度的高效液相色谱荧光检测方法,研究健康受试者口服盐酸曲马多口腔崩解片受试制剂和参比制剂的相对生物利用度和生物等效性。方法:20名男性健康志愿者随机分成2组,先后单剂量、交叉口服受试制剂和参比制剂100mg后,采用液相色谱-荧光测定方法测定血药浓度。结果:受试制剂和参比制剂的主要动力学参数为:tmax分别为(2.2±0.8)h和(2.5±0.7)h,Cmax(实测)分别为(284.8±161.4)μg.L-1和(283.9±166.6)μg.L-1;t1/2分别为(6.4±2.3)h和(6.3±3.2)h;AUC0→t分别为(1963.3±1154.6)μg.h.L-1和(1991.6±1296.1)μg.h.L-1,AUC0→∞分别为(2260.6±1309.1)μg.h.L-1和(2354.7±1643.4)μg.h.L-1。结论:经方差分析、双单侧t检验及90%置信区间法统计表明两制剂具有生物等效性。OBJECTIVE To establish HPLC with fluorescence detection method for determination of tramadol Hydrochloride in plasma and to study the relative bioavailability following oral administration of reference tramadol Hydrochloride capsules and trial tramadol Hydrochloride Orally Disintegrating Tablets in healthy volunteers. METHODS Healthy volunteers were orally given 100 mg of either tramadol Hydrochloride in an open randomized cross-over test. The tramadol Hydrochloride concentration in plasma was determined by HPLC with Fluorescence detection method. RESULTS Twenty volunteers were randomLy divided into 2 groups. The parameters of the test and reference formulation：tmax ,Cmax ,t1/2 ,AU0→24 were （2. 2 ± 0, 8）h and（2. 5 ±0.7）h. （284. 8± 161.4）μg·L^-1 and （283. 9±166. 6）μg·L^-1; （6.4±2.3）h and（6.3±3.2）h;（1 963.3±1 154.6）μg·h·L^-1 and （1 991.6 ± 1 296. 1）μg·h·L^-1 , respectively. CONCLUSION The two preparation were equivalent.

关 键 词：盐酸曲马多 口腔崩解片 液相色谱-荧光 相对生物利用度 

分 类 号：R969.4[医药卫生—药理学]